SUPerficial ENDometriosis In Magnetic Resonance Imaging

Not Applicable

Not yet recruiting

• Conditions: Endometriosis
• Interventions: Radiation: Magnetic resonance imaging, 3DT1 sequence; Procedure: Laparoscopy

• Registration Number: NCT06195280
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy.

Detailed Description

This is a prospective, multicenter, non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis.

The duration of the patient's participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy.

After selection, the investigator will check the patient's eligibility and offer her the study. If she accepts and signs the informed consent form, the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

After Magnetic Resonance Imaging, the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour.

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Start: 2025-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
superficial endometriosis	Magnetic resonance imaging, 3DT1 sequence	Endometriosis is a chronic, estrogen-dependent inflammatory disease secondary to tissue growth outside the uterine cavity, affecting approximately 10% of women of childbearing age.
superficial endometriosis	Laparoscopy	Endometriosis is a chronic, estrogen-dependent inflammatory disease secondary to tissue growth outside the uterine cavity, affecting approximately 10% of women of childbearing age.

Primary Outcome Measures

Name	Time	Method
Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy	between 30 and 150 days	The diagnostic validity of Magnetic resonance imaging compared to laparoscopy will be determined by correlation between the locations of the sites screened on Magnetic resonance imaging (Douglas cul de sac, vesicouterine cul de sac, right ovarian fossa, left ovarian fossa, right broad ligament, left broad ligament) and histologically confirmed endometriotic implants at these sites.

Trial Locations

Locations (1)

Clinique Blomet; 🇫🇷 Paris, France